A 2-week Repeated-dose Oral Toxicity Test of Polycalcium, a Mixed Composition of Polycan and Calcium Lactate-gluconate 1:9 (g/g)

摘要

A mixed composition of purified beta-glucan from Aureo-basidium pullulans and calcium lactate-gluconate 1 : 9 (gVg) (polycalcium) was administered orally to female and male Sprague-Dawley (SD) rats once per day for 14 days at doses of 0, 500,1,000 and2,000 mg/kg in a volume of 10 ml_/kg to investigate the effects of an oral repeated dose. After 14 days of oral polycalcium treatment, no treatment-related mortalities, clinical signs, or body/organ weight changes were detected. In addition, no meaningful polycalcium treatment-related changes were observed in hematological, serum biochemical, gross or histopathological parameters as compared with sex-matched vehicle controls following treatment with doses up to 2,000 mg/kg, the maximum dose limit for rodents. Therefore, polycalcium is non-toxic to rats and is therefore likely to be safe for clinical use.